Wideband Tympanometry in Otitis Media With Effusion

The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04395261

Enrollment

202

Registered

2020-05-20

Start date

2016-01-01

Completion date

2018-12-30

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media With Effusion

Brief summary

The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.

Detailed description

Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation. Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.

Interventions

DIAGNOSTIC_TESTWideband Tympanometry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.

Exclusion criteria

* The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.

Design outcomes

Primary

Measure	Time frame	Description
Resonance frequency	The same 1 day with the operation	Wideband resonance frequency was measured
Absorbance	The same 1 day with the operation	Wideband absorbance of frequencies between 250-8000 Hz were measured

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026